Psilocybin Efficacy With or Without Pimavanserin Pretreatment

Study acronym: PRISMatic
StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Start date pushed from Sep 30, 2026 to Oct 30, 2026
    • Eligibility criteria expanded, about 28 words
    • Publications: details revised at 3 of 3 entries
  2. Start date: Jul 2026 to Sep 30, 2026v4
  3. Recruitment opened
    • Eligibility criteria shortened, about 119 words
    • Site details revised
    v3
  4. Start date: Jun 2026 to Jul 2026v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration. The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.
Trial Details
NCT Number NCT07610135
Lead Sponsor Johns Hopkins University
Conditions
(from sponsor)		 Mood (Psychological Function), Well Being, Mood, Healthy
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov